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Friday, April 1, 2011

Conflict of interest reporting

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looks like using Google Chrome instead of IE8 solves the problem. Hmm.

This is the first of a two-part series on conflict of interest, medical ethics, and whether we can trust recommendations.

In several posts last year (Harvard Medical School limits outside income: a good start January 10, 2010, Statins and scientific integrity July 6,2010 and especially The AAFP, Coca-Cola, and Ethics: Serving the public interest? August 20, 2010), I discussed the question of conflict of interest, citing the work of ethicists such as Howard Brody, along with common sense, to demonstrate that a “conflict of interest” is simply that; a conflict between one set of a person or organization’s interests and another. In the case of the American Academy of Family Physicians (AAFP) and its relationship with the Coca-Cola Company or that between the American Dietetic Association (ADA) and Hershey’s Chocolate, the conflict is between what is in the best interests of the health of the patients that the AAFP’s member physicians or ADA’s member dieticians serve and what is in the best interests of Coke or Hershey (making money). The latter is only important to the professional organization because those companies share some of the money they make with them. In defending themselves against what appears to many people, both within and outside the organizations, to be corruption, the leaders who made these deals (such as then AAFP-President Lori Heim, MD) make the argument that only by looking at whether the information presented on the AAFP’s http://www.familydoctor.org/ website (for which Coke provided support) is biased (presumably toward Coke) can the presence of a conflict be determined.

This is patently absurd; the conflict is there, and along with it the suspicion that information may be skewed. This is particularly true when dealing with a site such as http://www.familydoctor.org/, on which the information is intended for the general public, not for professionals. Its value depends entirely upon the trust of the members of the public who use it, and such conflicts of interest undermine that trust. “How can I trust information provided on a medical site with ads from a company that my doctor says makes stuff that is bad for me – heck, that everyone knows is bad for them?” is a reasonable question, a reasonable suspicion, and a legitimate reason for concern by the public. “Hey, take our word for it; taking Coke’s money (or Hershey’s, in the case of the ADA) didn’t influence the content of the information on our website,” is a pretty weak defense, not one that is likely to engender trust of the organization or, of greater concern, of its member professionals.

The issue of conflict of interest has been a significant focus in the medical literature. Most major journals now require the authors of original research studies, particularly those that evaluate the effectiveness of drugs, to indicate if they have conflicts of interest; that is to say, financial connections with the manufacturer of the drug (or any other drug manufacturer or potential conflict of interest). This is in addition to identifying the source of funding for the study – mainly whether it was funded by a drug (or device) manufacturer as opposed to funded by the federal government (through NIH or another agency) or, much less common for such studies, a not-for-profit foundation. Again, the reason is obvious: if the author has a conflict of interest (gets money for speaking for a drug company, say, that manufactures the drug being examined, we all have reason to be more guarded in our interpretation of the results, or at least the confidence that we have that the study was done completely without bias. One problem is that bias can creep in unconsciously, even if there is not intentional fraud. Another problem is selective publication: we may only see the papers that report on studies where the drug had a positive benefit, because negative studies are suppressed; this is further complicated by the general preference of journals for positive results, regardless of who is funding the research. If the authors do not disclose their conflicts of interest, we have no way of knowing about them, and may not be sufficiently skeptical in interpreting the findings.

Am I saying we need to be skeptical? Is it not possible to be paid for speaking by a drug company and still do unbiased scientific research on their drugs? Is it not possible even when the drug company is funding the research? Of course it is possible, but unfortunately the data show that it is less likely. In the Introduction to their recent article in JAMA, Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments[1], Michelle Roseman and colleagues note that “Results from positive trials and from favorable analyses are more likely to be published than results unfavorable to sponsors. Compared with nonindustry-funded trials, pharmaceutical industry–funded studies more often yield results or conclusions in support of the sponsor's drug, and authors' relationships with drug manufacturers have been linked to favorable assessments of drug efficacy and safety,” with numerous references for each of these assertions. The actual focus of their study is to look at meta-analyses to see whether they report conflicts of interest (COIs) in the original studies that they are analyzing. Meta-analyses can be the most potent source of information about a question, as they analyze the results of many studies (ideally, all randomized controlled trials) on a particular topic, and if well done can help to resolve the question of conflicting results from different studies. Of course, if the studies that are included are in themselves biased (either intentionally or not) it will of course impact the results of the meta-analysis. Roseman and her colleagues found that, while the authors of the meta-analyses reveal their own conflicts of interest (if any), consistent with the policies of the journals they publish in, they rarely indicate whether the many studies that they are re-analyzing had such conflicts.

This can be important. For example, if the different studies examined by the meta-analysis tend to show differences in the benefit of a drug treatment, it would be good to know if the ones that showed greater benefit were sponsored by a drug company, or if the authors were on that drug company’s speaker’s bureau. It just might make a difference. Wealth makes a difference because it can buy loyalty, buy favors. The old saw “It is as easy to love a rich man as a poor one” can be modified to “it is as easy to use a product made by someone who pays you as by someone who doesn’t”. Or even “it is as easy to believe an idea supported by the rich and the powerful as one supported by only the poor and disenfranchised”. The problem is that the connections are not random – the ideas of the rich and powerful are too frequently self-serving, and “just so happen” to favor them over the poor and disenfranchised. An excellent example, featuring Ayn Rand and her disciple Alan Greenspan, is provided to us by Matt Taibbi in chapter 2 of his book “Griftopia”[2].

Then it isn’t as easy. Then it is corrupt. Then it is immoral. Then it is selling your soul.